Surgical devices comprising articulated members and methods for using the same

ABSTRACT

Surgical devices and methods for their use in manipulating internal body objects are provided. The subject devices have proximal and distal ends separated by an elongate member. Located at the distal end is at least one articulated member, and usually two or more articulated members. A manual means for actuating the one or more distal articulated members is located at the proximal end of the device. The elongate member may be flexible or rigid. The subject devices find use in a variety of applications, and are particularly suited for use in applications in which it is desired to manipulate an internal body object from a location external to the body.

CROSS-REFERENCE

[0001] This application is a continuation of Ser. No. 09/574,446, filedMay 19, 2000, which is incorporated herein by reference in its entiretyand to which application we claim priority under 35 USC §120.

INTRODUCTION

[0002] 1. Field of the Invention

[0003] The field of this invention is medical devices, and moreparticularly minimally invasive surgical devices.

[0004] 2. Background of the Invention

[0005] Minimally invasive medical techniques are aimed at reducing theamount of extraneous tissue which is damaged during diagnostic orsurgical procedures, thereby reducing patient recovery time, discomfort,and deleterious side effects. Of the large total number of surgeriesperformed in the United States each year, it is estimated thatsignificant proportion of these surgeries can potentially be performedin a minimally invasive manner. However, only a fraction of thispotential number currently use these techniques due to limitations inminimally invasive surgical instruments and techniques and theadditional surgical training required to master them.

[0006] Advances in minimally invasive surgical technology could have adramatic impact. The average length of a hospital stay for a standardsurgery is 8 days, while the average length for the equivalent minimallyinvasive surgery is 4 days. Thus, the complete adoption of minimallyinvasive techniques could save 28,000,000 hospital days, and billions ofdollars annually in hospital residency costs alone. Patient recoverytimes, patient discomfort, surgical side effects, and time away fromwork are also reduced with minimally invasive surgery.

[0007] The most common form of minimally invasive surgery is endoscopy.Probably the most common form of endoscopy is laparoscopy which isminimally-invasive inspection and surgery inside the abdominal cavity.In standard laparoscopic surgery, a patient's abdomen is insufflatedwith gas, and cannula sleeves are passed through small (approximately ½inch) incisions to provide entry ports for laparoscopic surgicalinstruments.

[0008] The laparoscopic surgical instruments generally include alaparoscope for viewing the surgical field, and working tools such asclamps, graspers, scissors, staplers, and needle holders. The workingtools are similar to those used in conventional (open) surgery, exceptthat the working end of each tool is separated from its handle by anapproximately 12 to 15-inch long extension tube.

[0009] To perform surgical procedures, the surgeon passes instrumentsthrough the cannula and manipulates them inside the abdomen by slidingthem in and out through the cannula, rotating them in the cannula,levering (i.e., pivoting) the instruments in the abdominal wall andactuating end effectors on the distal end of the instruments. Theinstruments pivot around centers of rotation approximately defined bythe incisions in the muscles of the abdominal wall. The surgeon monitorsthe procedure by means of a television monitor which displays theabdominal worksite image provided by the laparoscopic camera.

[0010] Similar endoscopic techniques are employed in arthroscopy,retroperitoneoscopy, pelviscopy, nephroscopy, cystoscopy, cisternoscopy,sinoscopy, hysteroscopy and urethroscopy.

[0011] The common feature of all of these minimally invasive surgicaltechniques is that they visualize a worksite within the human body andpass specially designed surgical instruments through natural orifices orsmall incisions to the worksite to manipulate human tissues and organsthus avoiding the collateral trauma caused to surrounding tissues whichwould result from creating open surgical access.

[0012] There are many disadvantages to current minimally invasivesurgical technology. For example, existing MIS instruments deny thesurgeon the flexibility of tool placement found in open surgery. Mostlaparoscopic tools have rigid shafts and are constrained to approach theworksite from the direction of the small incision. Additionally, thelength and construction of many endoscopic instruments reduce thesurgeon's ability to feel forces exerted by tissues and organs on theend effector of the tool. The lack of dexterity and sensitivity providedby endoscopic tools is a major impediment to the expansion of minimallyinvasive surgery.

[0013] As such, there is much interest in the development of newsurgical tools for use in minimally invasive procedures that address oneor more of the above disadvantages.

[0014] Relevant Literature

[0015] U.S. Patents of interest include: U.S. Pat. Nos. 5,997,567;5,976,122; 5,891,162; 5,820,009; 5,797,959; 5,728,121; 5,713,919;5,613,973; 5,549,636; 5,417,684; and 5,383,895. See also Doshi et al.,J. Rehabil. Res. Dev. (1998) 35:388-395.

SUMMARY OF THE INVENTION

[0016] Surgical devices and methods for their use in manipulatinginternal body objects are provided. The subject devices are elongateddevices having an elongate member with proximal and distal ends. Locatedat the distal end is at least one articulated member, and usually two ormore articulated members. A manual means for actuating the one or moredistal articulated members is located at the proximal end of the device.The elongate members may be flexible or rigid, and both embodiments areencompassed by the subject invention. The subject devices find use in avariety of applications, and are particularly suited for use inapplications in which it is desired to manipulate an internal bodyobject from a location external to the body.

BRIEF DESCRIPTION OF THE FIGURES

[0017]FIG. 1 provides a three-dimensional view of a first embodiment ofthe subject devices in which the elongate member is rigid, where thedevice is depicted in a first, retracted position.

[0018]FIG. 2 provides a three-dimensional view of the device shown inFIG. 1, where the device is depicted in the deployed position withfingers extended.

[0019]FIG. 3 provides a three-dimensional view of the device shown inFIG. 1, where the device is depicted in the flexed or engaged position.

[0020]FIG. 4 provides a three-dimensional view of the device shown inFIG. 1, where the device is depicted with one finger flexed or engaged,i.e., in a one-finger flexed position. This figure shows the ability ofthe articulated members or figures to move independently of each other.

[0021]FIG. 5 provides a cross-sectional view of a spring steel (oranalogous material) backed finger grasper segment found in certainembodiments of the subject devices.

[0022]FIG. 6 provides a three-dimensional view of device according toanother embodiment of the subject invention in which the elongate memberis flexible. In this depiction, the articulated members are portrayed inthe extended position.

[0023]FIG. 7 provides another three-dimensional view of the device shownin FIG. 6, wherein the articulated members are depicted in the flexedposition.

[0024]FIGS. 8A to 8C provide a depiction of another embodiment of thearticulated members, in which the segments are connected by joints whichhave torsion springs.

[0025]FIGS. 9A to 9B provide a representation of the articulated membersof a spreader device, in which the individual finger segments areconnected by joints which have torsion springs, analogous to thosedepicted in the grasper device of FIG. 8.

[0026]FIGS. 10A to 10C provides a three-dimensional view of a“memory-metal” embodiment of the articulate members of the subjectdevices.

DESCRIPTION OF THE SPECIFIC EMBODIMENTS

[0027] Surgical devices and methods for their use in manipulatinginternal body objects are provided. The subject devices have proximaland distal ends separated by an elongate member. Located at the distalend is at least one articulated member, and usually two or morearticulated members. A manual means for actuating the one or more distalarticulated members is located at the proximal end of the device. Theelongate member separating the proximal and distal ends may be rigid orflexible. The subject devices find use in a variety of applications, andare particularly suited for use in applications in which it is desiredto manipulate an internal body object from a location external to thebody. In further describing the subject invention, the subject deviceswill be described first both in general terms and in terms ofrepresentative embodiments depicted in the figures, followed by a reviewof representative applications in which the subject devices find use andkits that include the subject devices.

[0028] Before the subject invention is further described, it is to beunderstood that the invention is not limited to the particularembodiments of the invention described below, as variations of theparticular embodiments may be made and still fall within the scope ofthe appended claims. It is also to be understood that the terminologyemployed is for the purpose of describing particular embodiments, and isnot intended to be limiting. Instead, the scope of the present inventionwill be established by the appended claims.

[0029] It must be noted that as used in this specification and theappended claims, the singular forms “a,” “an,” and “the” include pluralreference unless the context clearly dictates otherwise. Unless definedotherwise all technical and scientific terms used herein have the samemeaning as commonly understood to one of ordinary skill in the art towhich this invention belongs.

[0030] Devices

[0031] As summarized above, the subject devices are devices for use inmanipulating internal body objects. As such, the subject devices aredevices for use in moving an object inside of a body of an animal. Afeature of the subject devices is that they are actuatable by anactuation means that is located outside of the body of the animal duringuse. In other words, the actuation means of the subject devices isseparated from the object moving means by a distance which provides forthe object moving means to be inside of the animal body and theactuation means to be outside of the body during use.

[0032] As such, the subject devices are elongate structures that have adistal end and a proximal end separated by a length of sufficientdistance to provide for the above features during use. The proximal endis defined as the end of the device that is not inside the animal bodyduring use, i.e. the end that is most distant or furthest away from theend of the device that is inside of the body during use. In other words,the proximal end of the device is the end of the device that is outsideof the body during use. In contrast, the distal end of the device is theend of the device that is inside of the body during use and the end atwhich at least one articulated member is located, where this feature isfurther described infra. As mentioned above, the proximal and distalends are separated by a distance sufficient to provide for the proximalend to be outside of the body and the distal end to be inside of thebody during use, where this distance will vary depending on theparticular application in which the device is to be used, e.g., whetherthe device is to be used in a laparoscopic procedure, to manipulate anobject at a vascular site, etc. As such, the distance between theproximal and distal ends in many embodiments of the subject inventiongenerally ranges from about 3 to 60, usually from about 10 to 50 andmore usually from about 12 to 50 inches. Depending on the particularapplication for which the device is intended to be employed, theelongate member may be rigid or flexible. Where the elongate member isrigid, e.g., as would be found in a device designed for use inlaparoscopic or other trocar sleeve accessed surgical procedures, thedistance between the proximal and distal ends typically ranges fromabout 3 to 20, usually from 12 to 18 and more usually from about 12 to15 inches. In those embodiments where the elongate member is flexible,i.e., in “catheter” embodiments of the subject invention where thedevice is to be used to manipulate an object positioned at a vascularsite or another site that is accessed through an analogous tortuous orat least curvilinear pathway, the distance between the proximal anddistal ends typically ranges from about 3 to 60, usually from about 10to 50 and more usually from about 20 to 50 inches.

[0033] Located at the distal end of the device is at least onearticulated member. In many embodiments, the device includes a pluralityof articulated members. By plurality is meant at least 2, where thenumber may range from 2 to 6, usually 2 to 4 and more usually 2 to 3. Incertain embodiments, the device includes a single articulated member.However, in many other embodiments, the device includes two articulatedmembers.

[0034] The number of joints in the finger may vary, but typically rangesfrom about 1 to 10, usually from about 2 to 4 and more usually fromabout 2 to 3. The length of each finger may vary depending on theparticular configuration of the device, e.g. laparoscopic or catheter,but generally ranges from about 0.25 inch to 6 inches, usually fromabout 0.5 inch to 4 inches and more usually from about 1 to 4 inches.The size of the fingers and elements from which they are madenecessarily varies with respect to the size of the object that they areintended to manipulate. For small scale object, i.e., objects having avolume ranging from about 0.01 to 0.25 cubic inches, usually from about0.02 to 0.20 cubic inches and more usually from about 0.05 to 0.125cubic inches, such as structures found in vascular locations, foodobjects in lungs, gall stones, etc., the length of each finger istypically at least about 0.25, usually at least about 0.3 and moreusually at least about 0.5 inches, where the length may be as long as 4inches or longer, but generally does not exceed about 3 and usually doesnot exceed about 2 inches. For large objects, i.e., objects having avolume ranging from about 27 to 125 cubic inches and usually from about40 to 100 cubic inches, e.g., tissues, organs, etc., the length of eachfinger is typically at least about 2, usually at least about 2.5 andmore usually at least about 3.0 inches, where the length may be as longas 6 inches or longer, but generally does not exceed about 5 and usuallydoes not exceed about 4 inches. In those embodiments where the deviceincludes a plurality (i.e. two or more) of articulated members (i.e.jointed fingers), all of the members may be of the same length or theymay have different lengths, where when the members are of differentlength, the magnitude of the difference in lengths typically ranges fromabout 0.5 to 3.0 inches, usually from about 1.0 to 2.0 inches. In manyembodiments, all of the articulated members are of the same length. Thehinges located at the joints of the finger elements may vary inconfiguration, where hinge configurations of interest include: torsionalsprings, compression joints, living hinges, and the like.

[0035] The articulated member(s) may have a number of distinctconfigurations. A feature of the subject devices is that the articulatedmember(s) is characterized by having at least one of the following twofeatures: (1) the presence of compression means for preventinghyperextension of the member; and (2) the absence of pinned hinges atthe joints. In certain embodiments, the articulated member of the deviceis one that has both of the above features, i.e. one that includes ahyperextension prevention compression means and lacks pinned hinges atits joints. In yet other embodiments, the articulated member includesonly one of the above features, i.e. it is one that has pinned hinges atits joints but also includes a compression means for preventinghyperextension or it is one that lacks pinned hinges at its joints anddoes not have a compression means for preventing hyperextension.

[0036] By compression means for preventing hyperextension is meant ameans that acts through compression, i.e. through two elements or massespushing into and against each other, to prevent hyperextension of themember. By hyperextension is meant a movement of the member beyond theextended state in a direction opposite the flexed state. Morespecifically, like human fingers the articulated members of the subjectinvention are capable of moving between two states: (1) an extendedstate in which the member is straight out or extended; and (2) a flexedstate in which the member is curled around itself to some extent. Thehyper-extended state would be one in which the member was bent arounditself to a certain extent in a direction opposite the flexed state. Interms of the analogy to a human finger, the hyper-extended state of ahuman finger would be one in which the finger was bent backwards awayfrom the palm of the hand and towards the back of the hand and beyondthe fully extended finger state. In the compression means of preventinghyperextension of the subject devices, two bodies are pressed togetherin the extended state of the member and are configured such that, whenpressed together, they prevent hyperextension of the finger. Anyconvenient compression means for preventing hyperextension may beemployed, where representative means are described infra.

[0037] As mentioned above, certain embodiments of the subject devicesare characterized by having joints that are not pinned hinge joints. Bypinned hinge joint is meant a joint in which a pin or analogousstructure is passed through a hole present at the intersection of twolongitudinal elements of the member or finger that holds the twolongitudinal elements together in a manner such that they can pivotabout each other. As the joints of the articulated members or fingersare ones that are not pinned hinges, they have a configuration thatprovides for the requisite pivot movement without a pinned hinge, whererepresentative non-pinned hinge joints are described in greater detailsupra.

[0038] In certain embodiments where the device includes a plurality ofarticulated members, i.e. two or more articulated members, eacharticulated member of the device is capable of being moved independentlyrelative to the other articulate member(s) of the device. In otherwords, one articulated member can be moved without moving the otherarticulated member or members of the device. While these embodiments inwhich the articulated members are independently movable may or may notinclude one or both of the above features, i.e. the presence of acompression means for preventing hyperextension or the absence of jointswith pinned hinges, in many of the devices of this embodiment at leastone of these features is present.

[0039] The direction that the articulate member(s) flexes in the subjectdevices may vary depending on the intended use of the subject device.For example, in certain embodiments the articulated member may flextowards the longitudinal axis of the device with which it is associated,e.g., towards the longitudinal of the tubular portion of the device fromwhich it protrudes at the distal end. This configuration is foundgenerally in grasper embodiments of the subject invention where thesubject device is employed to grab hold of or grasp an object, e.g.,tissue, organ etc. In yet other embodiments, the articulated member mayflex away from the longitudinal axis of the device with which it isassociated, e.g., away from the longitudinal axis of the tubular portionof the device from which it protrudes at the distal end. Thisconfiguration is found generally in spreader embodiments of the subjectinvention where the subject device is employed to separate or spreadobjects, e.g., organs or tissues.

[0040] In certain embodiments of the subject devices, the articulatedmember or members are capable of being retracted into and protruded froma protective housing located at the distal end of the elongate, e.g.tubular device. In many embodiments, the distal and proximal ends areseparated by an elongate tubular region that may be flexible or rigid,depending on the configuration of the device, as described supra. Inthese embodiments, the protective housing is simply the opening of thetube at the distal end through which the articulate members may beextended or retracted. As such, during introduction of the distal end ofthe device that includes the articulated members into the body duringuse, the articulated members or fingers may be retracted into theprotective housing to aid in placement of the device at the location ofthe internal object to be manipulated. After the distal end of thedevice has been positioned at the location of the object to bemanipulated, the fingers may be protruded from the protective housing.

[0041] As mentioned above, the distal and proximal ends are generallyseparated by an elongated tubular member. While in many embodiments thecross-sectional shape of the member is curvilinear and most typicallycircular, other cross-sectional shapes are possible, e.g. square,rectangular, trapezoidal, triangular etc. The longest cross sectionaldimension of the tubular elongate portion of the device may varydepending on the configuration of the device, but typically ranges fromabout 0.1 to 2.5, usually from about 0.3 to 2.0 and more usually fromabout 0.4 to 1.5 cm. In those embodiments of the device where theelongate member is rigid, the longest cross-sectional dimension of theelongate portion, e.g. the diameter of the tubular section, typically isat least about 0.1 cm, usually at least about 0.3 cm and more usually atleast about 0.4 cm, where the longest cross-sectional dimension may beas long as 2.5 cm or longer, but generally does not exceed about 2.0 cmand usually does not exceed about 1.5 cm. In those embodiments of thedevice where the elongate member is flexible, e.g. in the “catheter”embodiments of the subject devices, the longest cross-sectionaldimension of the elongate portion, e.g. the diameter of the tubularsection, typically is at least about 0.1 cm, usually at least about 0.15cm and more usually at least about 0.2 cm, where the longestcross-sectional dimension may be as long as 2.0 cm or longer, butgenerally does not exceed about 1.0 cm and usually does not exceed about0.75 cm.

[0042] In certain embodiments, the device further comprises anarticulated member locking means, which serves to lock the articulatedmembers in a given position, e.g., in a gripped position, in an openposition etc.

[0043] Located at the proximal end of the device is a manual actuationmeans for moving the distal articulated members between a first extendedposition and a second flexed position. In other words, a manual means ispositioned at the proximal end of the device for actuating thearticulate members to assume various configurations, e.g., extended,grasped, semi-grasped, etc. The manual actuation means may be present ina variety of different configurations, so long as it is capable ofproviding for the requisite manual control over the movement of thearticulate fingers during use of the device. As such, any manualactuation means that can be operated by hand from a site external to thebody and achieve the desired internal object manipulation or movementvia the internal articulated member(s) during use may be present on thedevice. The manual actuation means typically includes one or moreelements shaped or configured to be operated by fingers and/or a thumbwhich are operationally connected to the articulated members via wires,strings, cables, or other tensile elements, etc., to provide for thedesired articulate member movement. Manual actuation means of interestinclude adaptations of those described in U.S. Patents of interestinclude: U.S. Pat. Nos. 5,997,567; 5,976,122; 5,891,162; 5,820,009;5,797,959; 5,728,121; 5,713,919; 5,613,973; 5,549,636; 5,417,684; and5,383,895; the disclosures of which are herein incorporated byreference. Representative manual actuation means are described infra ingreater detail.

[0044] As mentioned above, many embodiments of the subject devicesinclude a means for moving the articulated members from a retracted to adeployed position, where the retracted position is used duringintroduction of the device into the body and the deployed position isused during manipulation of the internal body object with the device. Inmany of these embodiments, the device further includes at the proximalend a locking means for reversibly locking the articulated members inthe deployed position. Any convenient locking means may be employed,where a representative locking means is described further in terms ofthe figures, infra.

[0045] The individual elements of the subject devices may be fabricatedfrom any convenient material, where at least the distal portion of thedevice and elements present at the distal portion, e.g., the articulatedmembers, the elongate member, etc., are ones that are fabricated from abiocompatible material. Bicompatible materials of interest includebiocompatible polymers, where suitable biocompatible polymers include,but are not necessarily limited to: biocompatible polymers and/orelastomers. Suitable biocompatible polymers include, but are notnecessarily limited to, materials such as, for example, polyethylene,homopolymers and copolymers of vinyl acetate such as ethylene vinylacetate copolymer, polyvinylchlorides, homopolymers and copolymers ofacrylates such as polypropylene, polymethylmethacrylate,polyethylmethacrylate, polymethacrylate, ethylene glycol dimethacrylate,ethylene dimethacrylate and hydroxymethyl methacrylate, polyurethanes,polyvinylpyrrolidone, 2-pyrrolidone, polyacrylonitrile butadiene,polycarbonates, polyamides, fluoropolymers such aspolytetrafluoroethylene and polyvinyl fluoride, polystyrenes,homopolymers and copolymers of styrene acrylonitrile, cellulose acetate,homopolymers and copolymers of acrylonitrile butadiene styrene,polyvinylchloride, silicone rubber, polymethylpentene, polysulfones,polyesters, polyimides, polyisobutylene, polymethylstyrene and othersimilar compounds known to those skilled in the art. Suitable,biocompatible elastomers include, but are not necessarily limited to,biocompatible elastomers such as medical grade silicone rubbers,polyvinyl chloride elastomers, polyolefin homopolymeric and copolymericelastomers, urethane-based elastomers, and natural rubber or othersynthetic rubbers, fluorenated polymers (e.g., PTFE), and the like. Inthe catheter versions of the subject devices, the material from whichthe device is fabricated may include a radiodense material or some otherimaging means to allow for visualization, e.g., with fluoroscopy. Itshould be understood that these possible biocompatible materials areincluded above for exemplary purposes and should not be construed aslimiting.

[0046] In certain embodiments, the subject devices include a shapememory element or elements. Any convenient shape memory material whichprovides for the requisite features of flexibility and resumption ofconfiguration following removal of applied force may be employed inthese embodiments. As such, shape memory alloys find use. A variety ofshape memory alloys are known, including those described in: U.S. Pat.Nos. 5,876,434; 5,797,920; 5,782,896; 5,763,979; 5,562,641; 5,459,544;5,415,660; 5,092,781; 4,984,581; the disclosures of which are hereinincorporated by reference. The shape memory alloy that is employedshould generally be a biocompatible alloy. Specific biocompatible alloysthat find use include those nickle-titanium (NiTi) shape memory alloyssold under the Nitinol™ name by Memry Corporation (Brookfield, Conn.);spring steel, etc. Also of interest are shape memory polymeric orplastic materials, where such materials include polypropylene,polyethylene, etc.

[0047] The subject devices may be manufactured using any convenientprotocol, where suitable protocols are known in the art. Representativemanufacturing methods that may be employed include machining, extrusion,and the like.

[0048] Turning now to the figures, FIG. 1 provides a three-dimensionalview of a first embodiment of the subject devices in which the elongatemember is rigid, where the device is depicted in a first, retractedposition. The device shown in FIG. 1 has rigid elongate member 6. At thedistal end of the elongate member 6 are the retracted articulatedmembers. At the proximal end of elongate member 6 is the manualoperation means. The manual operation means is made up of handle 5,locking means 4, triggers 7 a and 7 b, retractor/rotator element 1,connector 3 (which serves to structure connect the retractor/rotator 1to the articulate members at the distal end such that when theretractor/rotator is moved, the articulated members move in the samefashion), tensile element 2 and pins 8 a and 8 b (for independentlymoving the articulated members with the triggers). Retractor/rotatorelement 1 provides for retraction and deployment of the fingers at thedistal end of the device, as well as rotation of the fingers at thedistal end of the device.

[0049]FIG. 2 provides a three-dimensional view of the device shown inFIG. 1, where the device is depicted in the deployed position.Retractor/rotator element 1 is pushed forward and locked into positionby locking means 4, thereby moving the articulated members out of theelongate member 6 into the deployed position. This element can berotated to provide for analogous rotation of the deployed fingerelements. The articulated members or fingers are joined at element 13.As shown in FIG. 2, each articulated member is made up of 3 fingerelements (10 a, 11 a and 12 a or 10 b, 11 b and 12 b) where each fingeris backed by shape memory element (9 a or 9 b) that runs the length ofthe finger.

[0050]FIG. 3 provides a three-dimensional view of the device shown inFIG. 1, where the device is depicted in the gripped position. To achievethe gripped position, triggers 7 a and 7 b are pulled back toward handle5 as shown in FIG. 3. This movement causes elements 8 a and 8 b to pullback on tensile element 2, which in turn causes the finger elements togrip inward in a direction opposite the force of the shape memorybacking.

[0051]FIG. 4 provides a three-dimensional view of the device shown inFIG. 1, where the device is depicted with one finger flexed and theother finger extended. To achieve this position, only trigger 7 b ispulled back while trigger 7 a is not. This figure demonstrates that thearticulated members are independently actuatable.

[0052]FIG. 5 provides a cross-sectional view of a spring steel backedfinger grasper segment found in certain embodiments of the subjectdevices. As shown in FIG. 5, when tensile element 2 is pulled, it causesa moment resisted by the spring backing 9. As the moment created bytensile element 2 increases, the finger segment rotates and creates thegrasping motion.

[0053]FIG. 6 provides a three-dimensional view of device according toanother embodiment of the subject invention in which the elongate member15 is flexible. In this depiction, the articulated members are portrayedin the extended position.

[0054]FIG. 7 provides another three-dimensional view of the device shownin FIG. 6, wherein the articulated members are depicted in the graspedposition.

[0055]FIGS. 8A to 8C provide a depiction of a close up view ofarticulated members in which the segments are joined by pinned hingesand the return force is provided by the torsion springs. In FIG. 8A, thefingers are shown in the retracted position. The fingers are joined atelement 16. The fingers are made up of three jointed members, i.e., 18a, 20 a and 21 a or 18 b, 20 b and 21 b. Between each jointed member andthe joint 16 is torsion spring joint, shown in the figure as 17 and 19.FIG. 8B shows the same articulated member configuration in thesemi-flexed or semi gripped position while FIG. 8C shows the samearticulated member configuration in the fully flexed or grippedconfiguration. Also shown in these figures is string or cable element 2.

[0056]FIGS. 9A to 9B provide a representation of the articulated membersof a spreader device, in which the individual finger segments are joinedby pinned hinges and the return force is provide by the torsion springs,analogous to those depicted in the grasper device of FIG. 8. FIG. 9Ashows the device in the retracted position and FIG. 9B shows the devicein the deployed, flexed spread position.

[0057]FIGS. 10A to 10C provides a three-dimensional view of a“memory-metal” embodiment of the articulate members of the subjectdevices. In this embodiment, each finger is made up of a strip of memorymetal which assumes the configuration of FIG. 10B when deployed. Pullingof element 2 produces the gripped configuration as shown in FIG. 10C.

[0058] Utility

[0059] The subject devices find use in methods in which an internalobject inside an animal is manipulated from a site external to theanimal. As such, the subject devices are suited for use in minimallyinvasive or “non-open” surgical procedures in which an internal bodyobject is manipulated from a location outside of the animal. Bymanipulated from a site or location outside of the animal is meant thatthe surgeon or analogous health care professional's hands are present ata site outside of the animal and, via the device, remotely manipulatetissue inside the animal.

[0060] The subject devices may be used to remotely manipulate internalbody objects in a variety of different manners depending on theparticular design of the device being employed. For example, in certainembodiments the devices may be employed to grasp or hold internal bodyobjects. In yet other embodiments, the subject devices may be employedto separate or spread internal body objects from each other.

[0061] A variety of different types of internal body objects may bemanipulated using the subject devices and methods. The term “internalbody object” is used broadly to refer to any type of object or structurethat is inside the animal body, i.e., not on the surface or epidermis ofthe animal. Representative structures that may be manipulated employingthe subject devices in the subject methods include: tissues, organs orparts thereof, internal vascular objects, e.g., vascular obstructions orlesions, food particles and other foreign body objects, and the like.

[0062] The subject methods and devices find use with a variety ofdifferent types of animals. Representative animals with which thesubject methods and devices find use include, but are not limited to:canines; felines; equines; bovines; ovines; etc. and primates,particularly humans.

[0063] Kits

[0064] Also provided are kits that at least include the subject devices.The subject kits at least include a device of the subject invention andinstructions for how to use the device in a procedure. The instructionsare generally recorded on a suitable recording medium. For example, theinstructions may be printed on a substrate, such as paper or plastic,etc. As such, the instructions may be present in the kits as a packageinsert, in the labeling of the container of the kit or componentsthereof (i.e. associated with the packaging or subpackaging) etc. Inother embodiments, the instructions are present as an electronic storagedata file present on a suitable computer readable storage medium, e.g.CD-ROM, diskette, etc. The instructions may take any form, includingcomplete instructions for how to use the device or as a website addresswith which instructions posted on the world wide web may be accessed.

[0065] The following examples are offered by way of illustration and notby way of limitation.

EXPERIMENTAL

[0066] I. Use of the Device

[0067] A. Laparoscopic Application:

[0068] The device shown in FIG. 1 is inserted through the appropriatelysized trocar sleeve into the abdominal cavity. Next, the fingers areadvanced through the sheath. Following advancement through the sheath,the fingers spring into their preferred, deployed shape. This preferredshape is one in which the fingers are positioned away from each other.At this point, the rotator/retractor knob (element 1 as shown in FIG. 1)on the proximal end is locked into position by locking element 4,locking the inner cylinder(connector 3)/fingers in relation to the outersheath. Now, the proximal handle is manipulated through flexion of theoperator's fingers to cause flexion of the fingers located on the distalend of the device. This flexion of the distal fingers of the deviceallows grasping of various sized objects, including, but not limited to,the gall bladder, gall stones, colon, spleen, kidney, adrenals glands,stomach, and pancreas.

[0069] Other non-laparoscopic applications in which the grasping devicedepicted in FIG. 1 finds use include, but are not limited to, orthopedicapplications (including arthroscopy), urologic applications,cardiothoracic applications (including on and off pump cardiacoperations), and obstetric/gynecologic applications. The use of a trocarsleeve to facilitate entry/exit of the device may or may not berequired.

[0070] B. Catheter Application (Retrieval of Foreign Body in Lung)

[0071] In this case, the catheter based version of the device as shownin FIGS. 6 and 7 is used as follows. In the case of retrieval of aforeign body from the lungs, a rigid or flexible bronchoscope isadvanced thorough the pulmonary tree (trachea, bronchus, bronchioloes)until the foreign body (e.g. a food item) is located. At this point, thecatheter is advanced through the lumen of the bronchoscope, and underbronchoscopic visualization, the foreign body is grasped by the distalaspect of the device. Next, the bronchoscope and catheter device areremoved together, pulling out the foreign body as the devices arethemselves removed.

[0072] Alternative catheter-based applications include but are notlimited to interventional cardiology, interventional radiology, andneurointerventional radiology. Applications may include retrieval offoreign objects or other objects such as thrombus or emboli. Otherapplications also include gastroenterology which might involve retrievalof foreign objects within the alimentary tract using fluoroscopic orendoscopic guidance.

[0073] It is evident that the subject devices provide for a number ofimportant advantages over prior art minimally invasive surgical tools.The subject devices show great dexterity in that one can grasp and shiftinternal objects easily by individually flexing the articulated membersand rotating the members. Furthermore, the subject devices are able tocurve around and grab an object without applying excessive or damagingforce to the object, much like a human finger. In other words, thesubject devices may be used to manipulate both small and large objectswith great dexterity in an atraumatic way. Furthermore, certainembodiments of the device provide the ability to grasp large objects.The subject devices are also easy to master and use, and are applicableto a large number of different applications. As such, the subjectinvention represents a significant contribution to the art.

[0074] All publications and patent applications cited in thisspecification are herein incorporated by reference as if each individualpublication or patent application were specifically and individuallyindicated to be incorporated by reference. The citation of anypublication is for its disclosure prior to the filing date and shouldnot be construed as an admission that the present invention is notentitled to antedate such publication by virtue of prior invention.

[0075] Although the foregoing invention has been described in somedetail by way of illustration and example for purposes of clarity ofunderstanding, it is readily apparent to those of ordinary skill in theart in light of the teachings of this invention that certain changes andmodifications may be made thereto without departing from the spirit orscope of the appended claims.

What is claimed is:
 1. A surgical device comprising: proximal and distalends; at least one articulated member located at said distal end,wherein said articulated member comprises compression means forpreventing hyperextension of said member; and a manual actuation meanslocated at said proximal end for actuating said at least one articulatedmember.
 2. The surgical device according to claim 1, wherein said devicecomprises a plurality of articulated members.
 3. The surgical deviceaccording to claim 2, wherein said device comprises two articulatedmembers.
 4. The surgical device according to claim 1, wherein saiddevice comprises a rigid elongate member separating said proximal anddistal ends.
 5. The surgical device according to claim 1, wherein saiddevice comprises a flexible elongate member separating said proximal anddistal ends.
 6. The surgical device according to claim 1, wherein saidat least one articulated member is retractable into a protective housinglocated at said distal end.
 7. The surgical device according to claim 1,wherein said at least one articulated member comprises joints that arenot pinned hinges.
 8. The surgical device according to claim 2, whereinsaid articulated member of said plurality is individually actuatablerelative to any other articulated member of said plurality.
 9. Asurgical device comprising: proximal and distal ends; at least onearticulated member located at said distal end, wherein said articulatedmember comprises joints that are not pinned hinge joints; and a manualactuation means located at said proximal end for actuating said at leastone articulated member.
 10. The surgical device according to claim 9,wherein said device comprises a plurality of members.
 11. The surgicaldevice according to claim 10, wherein said device comprises twoarticulated members.
 12. The surgical device according to claim 9,wherein said device comprises a rigid elongate member separating saidproximal and distal ends.
 13. The surgical device according to claim 9,wherein said device comprises a flexible elongate member separating saidproximal and distal ends.
 14. The surgical device according to claim 9,wherein said at least one articulated member is retractable into aprotective housing located at said distal end.
 15. The surgical deviceaccording to claim 10, wherein said articulated member of said pluralityis individually actuatable relative to any other articulated member ofsaid plurality.
 16. The surgical device according to claim 9, whereinsaid at least one articulated member comprises compression means forpreventing hyperextension of said member.
 17. A surgical devicecomprising: proximal and distal ends; a plurality of articulated memberslocated at said distal end, wherein each articulated member of saidplurality is individually actuatable relative to any other articulatedmember of said plurality; and a manual actuation means located at saidproximal end for independently actuating each articulated member of saidplurality.
 18. The surgical device according to claim 17, wherein saiddevice comprises two articulated members.
 19. The surgical deviceaccording to claim 17, wherein said device comprises a rigid elongatemember separating said proximal and distal ends.
 20. The surgical deviceaccording to claim 17, wherein said device comprises a flexible elongatemember separating said proximal and distal ends.
 21. The surgical deviceaccording to claim 17, wherein said plurality is retractable into aprotective housing located at said distal end.
 22. The surgical deviceaccording to claim 17, wherein each articulated member of said pluralitycomprises compression means for preventing hyperextension of saidmember.
 23. The surgical device according to claim 17, wherein eacharticulated member of said plurality comprises joints that are notpinned hinge joints.
 24. A method for manipulating an object inside abody, said method comprising: introducing the distal end of a surgicaldevice comprising at least one articulated member according to claims 1,9 or 17 into said body; and manipulating said object with said at leastone articulated member; whereby said object is manipulated inside saidbody.
 25. The method according to claim 24, wherein said devicecomprises a rigid elongate member separating said proximal and distalends.
 26. The method according to claim 24, wherein said devicecomprises a flexible elongate member separating said proximal and distalends.
 27. A kit for use in a method according to claim 24, said kitcomprising: a surgical device according to claims 1, 9 or 17; andinstructions for using said device.